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Applications for extension of indications to align with a reference product can be submitted via the Variation e-form. This electronic form is available through the TBS portal.
For further information see:
- Extension of indications to align with a reference product in Variations to prescription medicines: excluding variations requiring evaluation of clinical or bioequivalence data (for chemical entities).
- Extension of indications to align with a reference product in Variations to prescription medicines - excluding variations requiring evaluation of clinical or bioequivalence data: process guidance.